TroCare TroKit Laparoscope Lens Wiper (CP000626)— 510(k) K241796

Substantially Equivalent

TroCare, LLC

FDA 510(k) clearance K241796 for TroCare TroKit Laparoscope Lens Wiper (CP000626), Substantially Equivalent on 2024-10-04. Applicant: TroCare, LLC.

Clearance details

Applicant: TroCare, LLC
Product code: Code GCJ
Advisory panel: Gastroenterology, Urology
Date received: 2024-06-21
Decision date: 2024-10-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Houston, TX, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code GCJ

product code GCJ

Death: 39
Injury: 1,638
Malfunction: 28,216
Other: 11
Total: 29,904

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.